Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery
Primary Purpose
Rotator Cuff Tear Arthropathy, Spine Degeneration
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Benzoyl peroxide
Sponsored by
About this trial
This is an interventional prevention trial for Rotator Cuff Tear Arthropathy
Eligibility Criteria
Inclusion Criteria:
- patients > 18 yrs.
- Primary prosthetic shoulder surgery.
- Instrumented primary surgery of the spine.
Exclusion Criteria:
- active infection.
- previous surgeries.
- interventionism prior to surgery in the last 6 months (infiltrations, arthro-CT, arthro-MRI)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Patients without Benzoyl peroxide
Patients with Benzoyl peroxide
Arm Description
Outcomes
Primary Outcome Measures
Cutibacterium acnes
isolation of Cutibacterium acnes in the deep tissues
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05355844
Brief Title
Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery
Official Title
Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.
Detailed Description
Shoulder prosthetic surgery as well as interventional surgery on the spine are commonly contaminated by Cutibacterium Acnes. Although the significance of this contamination is unknown, it represents a cause for concern since in some patients, contaminating Cutibacterium Acnes from surgery may develop long-term infection of the implant. Unlike knee and hip surgeries, where the most common infection-causing germs are Staphylococcus aureus, in shoulder and spine surgery, Cutibacterium Acnes represents one of the germs most frequently associated with infections. peri implant. Skin preparation with chlorhexidine as well as antibiotic prophylaxis with cefazolin have been shown to be ineffective in eradicating Cutibacterium Acnes. Recently, different studies support the use of benzoyl peroxide in topical application, to reduce the load of Cutibacterium acnes on the skin. Despite this, it has not been shown to reduce the rate of infection, nor to reduce the phylotypes of Cutibacterium acnes associated with peri-implant infections (IA, IB and II).
Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear Arthropathy, Spine Degeneration
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients without Benzoyl peroxide
Arm Type
Sham Comparator
Arm Title
Patients with Benzoyl peroxide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide
Intervention Description
Benzoyl peroxide application in the incision area before surgery
Primary Outcome Measure Information:
Title
Cutibacterium acnes
Description
isolation of Cutibacterium acnes in the deep tissues
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients > 18 yrs.
Primary prosthetic shoulder surgery.
Instrumented primary surgery of the spine.
Exclusion Criteria:
active infection.
previous surgeries.
interventionism prior to surgery in the last 6 months (infiltrations, arthro-CT, arthro-MRI)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Torrens, MD
Phone
003493674100
Ext
4201
Email
CTorrens@psmar.cat
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery
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